Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up

NCT06615843 | Recruiting

• 2 other identifiers: APHP2305862023-A02336-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The GYNAB study aims to compare patient satisfaction and clinical outcomes between dematerialized post-emergency gynecological follow-up using a connected health app and traditional in-person follow-up. Conducted by Drs. Laëtitia CAMPIN and Louis MARCELLIN at Hôpital Cochin, it is sponsored by Assistance Publique - Hôpitaux de Paris. The main objective is to assess patient satisfaction at day 7 on a scale from 0 to 10, considering symptom management, follow-up quality, and task performance. Secondary objectives include comparing satisfaction at day 28, PROM-ED scores for symptom relief, understanding, reassurance, and care planning at days 7 and 28, hospitalization rates, unscheduled consultations, surgical interventions, total hospital time by day 28, and physician satisfaction at 28 days. This randomized trial involves women aged 18-60 needing follow-up for conditions like genital infections, non-complicated ectopic pregnancies, unlocated pregnancy, first trimester metrorrhagia, miscarriages , and severe vomiting before 12 weeks. Inclusion criteria are women aged 18-60 needing specified follow-up. Exclusion criteria are severe clinical intolerance, severe criteria ultrasound findings, non-French speakers, and inability to use digital applications. The intervention group uses a connected health app for data collection and communication, logging symptoms and test results, with medical team notifications for urgent updates. The control group receives traditional in-person follow-up with scheduled consultations and emergency contact information. The study hypothesizes that digital follow-up will improve patient experience, reduce hospital visits, and provide comparable or superior satisfaction and clinical outcomes. The results could promote broader digital health adoption in various medical fields.

Conditions

Ectopic Pregnancy; Uncertain Viability of Pregnancy; Genital Diseases, Female; Abortion, Missed; Hyperemesis Gravidarum

Keywords

Gynecological Emergencies; Post-Emergency Follow-Up; Patient-Reported Outcome Measures (PROMs); Digital Health; Patient satisfaction; Telehealth; Asynchronous Medical Follow-up

Outcome Measures

Primary Outcomes (1)

• Overall Patient Satisfaction

  Measure of overall patient satisfaction with post-emergency gynecological follow-up, assessed on a scale from 0 to 10. This includes symptom management, follow-up quality, and the ability to perform requested tasks.

  7 days after initial emergency gynecological consultation

Secondary Outcomes (14)

• Overall Patient Satisfaction at 28 Days

  28 days after initial emergency gynecological consultation

• PROM-ED Score for Symptom Relief

  7 days after initial emergency gynecological consultation

• PROM-ED Score for Symptom Relief at 28 Days

  28 days after initial emergency gynecological consultation

• PROM-ED Score for Understanding

  7 days after initial emergency gynecological consultation

• PROM-ED Score for Understanding at 28 days

  28 days after initial emergency gynecological consultation

Study Arms (2)

Traditional In-Person Follow-Up

NO INTERVENTION

Participants in this arm will receive traditional in-person follow-up at the hospital. They will have scheduled consultations at the emergency department where they will undergo necessary evaluations and receive instructions for follow-up visits. Contact information for urgent needs will also be provided, allowing patients to reach medical services 24/7 if required

Dematerialized Follow-Up

EXPERIMENTAL

Participants in this arm will receive post-emergency gynecological follow-up at home using a connected health app.

Device: Participants will receive post-emergency gynecological follow-up at home using a connected health app

Interventions

Participants will receive post-emergency gynecological follow-up at home using a connected health app DEVICE

The app will facilitate data collection and communication, including logging of vital signs, symptoms (such as pain, bleeding, and vomiting), and uploading of test results. Medical professionals will review the health data twice daily and provide care instructions through instant messaging. The app will also alert the medical team of any urgent updates or deviations from expected health patterns

Dematerialized Follow-Up

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 and 60 years
• No consultation at the gynecological emergency department in the previous month and/or for the same pregnancy.
• Requires post-emergency follow-up for one of the following clinical conditions:
• Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment
• Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU \< 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \< 5000, compliant patient, no contraindications for Methotrexate
• Early Pregnancy of Uncertain Viability (GLI): Early stage with a positive bHCG test, no visible gestational sac on ultrasound, no effusion, bHCG \< 1500 IU
• Missed Miscarriage (GAM): Confirmed by an intrauterine gestational sac ≥ 25mm without an embryo or an intrauterine gestational sac with an embryo ≥ 7mm without visible cardiac activity, treated with Misoprostol
• First Trimester Bleeding (MTRt1): Moderate vaginal bleeding with an ongoing intrauterine pregnancy without hemodynamic instability
• Hyperemesis Gravidarum (VG): Severe vomiting before 12 weeks of pregnancy without severe criteria necessitating emergency follow-up

You may not qualify if:

• Severe clinical intolerance, defined by:
• Signs of severe sepsis with unstable hemodynamics (TA with SBP \< 90 mmHg and FC ≥ 105 bpm)
• Abdominal defense or contracture
• Pain not controlled by level 1 analgesics (EVA \<7)
• Severe dehydration defined by a body weight loss of more than 10%
• Total food intolerance due to vomiting necessitating hospitalization
• Uncontrolled active hemorrhage
• Significant ultrasound findings:
• Tubo-ovarian abscess ≥ 3 cm
• Significant intra-abdominal effusion
• Non-French speaking patients
• Inability to download or use the digital application due to precarious or isolated digital circumstances
• Refusal to sign consent form
• Patients under legal guardianship or court protection (tutelage, curatorship, or guardianship)
• Patients not affiliated with a social security system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female; Pregnancy, Ectopic; Abortion, Missed; Hyperemesis Gravidarum; Patient Satisfaction

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications; Abortion, Spontaneous; Morning Sickness; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Louis MARCELLIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Laetitia CAMPIN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia CAMPIN, MD

CONTACT

33 015413680; laetitia.campin@aphp.fr

Valérie PLENCE

CONTACT

33 0158411178; valerie.plence-fauroux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (1)